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Procedure Kit Straight Compression Plate 10 hole with 2.7mm Instruments Ti
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Procedure Kit Straight Compression Plate 10 hole with 2.7mm Instruments Ti FDA UDI
- Generic Name
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI
- Model / Reference
- PK-SCP2710.TI FDA UDI
Identifiers
- Catalog Number
- PK-SCP2710-TI FDA UDI
- Primary DI / UDI-DI
- B562PKSCP2710TI0 FDA UDI
- 510(k) Number
- K180736 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Procedure Kit Straight Compression Plate 10 hole with 2.7mm Instruments Ti by Wishbone Medical Inc. — Class II — FDA UDI — listed in FDA GUDID
Cleared under the same submission
K180736 also covers:
- 2.7mm x 12mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 12mm Ti Locking Screw — WISHBONE MEDICAL INC.
- 2.7mm x 14mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 14mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 16mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 18mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 18mm Ti Locking Screw — WISHBONE MEDICAL INC.
- 2.7mm x 18mm Ti Locking Screw — WISHBONE MEDICAL INC.
- 2.7mm x 20mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 22mm Ti Cortical Screw — WISHBONE MEDICAL INC.
- 2.7mm x 22mm Ti Locking Screw — WISHBONE MEDICAL INC.
- 2.7mm x 24mm Ti Locking Screw — WISHBONE MEDICAL INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Wishbone Medical Inc.
Sources (1)
- FDA UDI 5ff7899d-e2ad-4df8-8e63-5375b736c337 35 fields · synced May 29, 2026